BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT

    K Number: K120922 · Decision Feb 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    7
    Review Days
    317

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    Basic Information

    Device Name
    GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
    K Number
    K120922
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Selectivemed Components, Inc.
    Date Received
    March 27, 2012
    Decision Date
    February 7, 2013
    Product Code
    IPF
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IPF Stimulator, Muscle, Powered

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    Other Clearances by Selectivemed Components, Inc.

    K Number Device Name
    K083756 GUARDIAN 150 ELECTRODE
    K031053 SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
    K020476 MEDION 6000
    K993081 IO-DRIVE
    K946230 ENDURA REUSABLE TENS AND NMES ELECTRODES
    K945676 GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES